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Solid TumourPhase 2RADNCT01046461

Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer

A Phase 2 study testing Ramosetron, Aprepitant, Dexamethasone in people with Solid Tumour and Postoperative Nausea and Vomiting, run by Hallym University Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Ramosetron, Aprepitant, Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteSouth Korea
Study dates
Jan 2010to Jun 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 -75 years, both sex
  • ECOG performance status 0-2
  • Histologically proven solid cancer, chemotherapy-naïve patient
  • Planed to receive cisplatin (≥ 50mg/m2) based, single day chemotherapy,
  • No nausea or vomiting within 72 hours prior to chemotherapy
  • Serum Cr < 2.5 mg/dl, or calculated CCr ≥ 50 ml/min
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  • Serum total bilirubin < 2 mg/dl, AST/ALT < 3 times the upper normal limit , ALP < 5 times the upper normal limit
  • Absolute neutrophil count ≥ 1,500/μL, platelet ≥ 100,000/μL
  • Expected life duration ≥ 3 months
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Who cannot join

  • Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, active gastric or duodenal ulcers, or pregnancy or breast-feeding
  • Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases
  • Patients taking any medicine, which could affect study results, within 1 week before chemotherapy (or taking anti-emetics within 48 hours before chemotherapy). Prior to beginning chemotherapy, single-agent benzodiazepines as hypnotic is allowed, but it can't be receiving during day 1-6 of 1st chemotherapy cycle.
  • Patients with symptomatic brain metastasis
  • Patients with GI obstruction or other diseases that could provoke nausea and vomiting
  • Patients receiving RT on brain, abdomen or pelvis within 2 weeks before chemotherapy
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  • Patients who cannot understand informed consent or express his/her condition
  • Patients who cannot swallow drugs
  • Patients who have known allergy or severe side effect on study drugs

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 431-070

Other trials in South Korea

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3 receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.

But until now, there was no information that which 5-HT3 receptor antagonists is the best partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to assess the efficacy and tolerability of a combination of ramosetron, aprepitant and dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients with solid cancer

Read the detailed description

Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.

Being tested
Ramosetron, Aprepitant, Dexamethasone
Keywords
Ramosetron, aprepitant, dexamethasone, cancer, chemotherapy, antiemetics, cisplatin, nausea, vomiting, high dose cisplatin
Medical subject headings
Postoperative Nausea and Vomiting, Neoplasms, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ramosetron, Aprepitant, DexamethasoneDrug

    Also called Nasea, Emend

    Day 1:

    Aprepitant 125 mg PO, 1 hour before chemotherapy Ramosetron 0.6 mg IV, 30 min before chemotherapy Dexamethasone 12 mg PO, 30 min before chemotherapy

    Day 2 - 3:

    Aprepitant 80 mg PO. in the morning Dexamethasone 8 mg PO. in the morning

    Day 4 Dexamethasone 8 mg PO. in the morning

Study groups in NCT01046461
Study groupRoleWhat they receive
Ramosetron, Aprepitant, DexamethasoneExperimentalNot described
Receives: Drug: Ramosetron, Aprepitant, Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response (CR) rate of RAD for the prevention of chemotherapy induced nausea vomiting (CINV) during overall phase (form 1 to 5 days) (overall phase is defined as acute and delayed phase)

    Measured: from chemotherapy day 1 to day 5

Secondary outcomes (4)

  1. CR rate of RAD for the prevention of acute and delayed phase of CINV (from 0 to 24 hours /from 2 to 5 days)

    Measured: until 1 month after chemotherapy

  2. Severity of nausea

    Measured: until 1 month after chemotherapy

  3. Time to first occurrence of vomiting

    Measured: until 1 month after chemotherapy

  4. Adverse events reported using CTCAE v3.0

    Measured: until 1 month after chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2012 (estimated)
  4. Study completionJun 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01046461
Sponsor's protocol ID
RAD1.0
Acronym
RAD
Status last verified
Feb 2012
First submitted
8 Jan 2010
Last updated
17 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramosetron, Aprepitant, Dexamethasone in people with Solid Tumour and Postoperative Nausea and Vomiting, run by Hallym University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate of RAD for the prevention of chemotherapy induced nausea vomiting (CINV) during overall phase (form 1 to 5 days) (overall phase is defined as acute and delayed phase) (time frame: from chemotherapy day 1 to day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01046461.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012; AzTrials last refreshed its copy on 26 Oct 2026.

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